PROJECT SUMMARY/ ABSTRACT Facial appearance and facial dissatisfaction are critical components of health-related quality of life (HRQOL). Children with facial clefting often have physical differences that make them especially vulnerable to concerns with facial form. Although surgical and psychological interventions exist to improve appearance and alleviate elements of facial dissatisfaction, existing measures that capture self-perceived appearance are highly variable and lack the sensitivity to assess clinically meaningful change across a broad range of facial differences. Thus, a standardized, generic measurement system that can precisely assess facial form and facial deformity across a broad range of conditions is essential. In order to address this critical gap, we aim to create a novel instrument using state-of-the-art methodology based upon established Patient Reported Outcome Measurement Information System (PROMIS) standards in order to sensitively assess the impact that facial dissatisfaction has on HRQOL. This instrument, PROMIS-Face, will be appropriate for use in clinical populations, as well as in the general population. We will implement a mixed methods design to create item banks that assess critical aspects of appearance among children with cleft lip and palate (CLCP) and among normally developing controls. Facial dissatisfaction domains will be identified and corresponding items will be developed through qualitative analysis from semi-structured and cognitive interviews, respectively. Newly developed items will then be tested in a large, diverse sample of children with CLCP, as well as in a matched sample of normally developing children. A state-of-the-art approach employing both classical and contemporary methods of test construction and validation?including Item Response Theory and Computerized Adaptive Testing technology?will be utilized to develop the final item banks. This proposal represents one of the first efforts to systematically examine facial appearance and dissatisfaction within the cleft population and integrate this important facet of childhood development into existing measures of health status. Our instrument will be immediately relevant for clinicians in practice and researchers interested in identifying and quantifying the burden of facial dissatisfaction in patients with facial differences. Moreover, our findings will provide a robust foundation for future studies that seek to extend and refine these measures for use among individuals of all ages and across a variety of conditions.